A Multi-centered, Double-blind, Randomized, Placebo-controlled Study of TEV-56286 for the Treatment of Multiple System Atrophy
- Conditions
- Multiple System AtrophyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-505320-54-00
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Is a male or female =30 years old at screening., Is considered to be clinically possible” or clinically probable” MSA as determined by the Gilman criteria., Is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive devices (eg, walker or cane) is allowed.
Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), other than MSA that, in the opinion of the investigator, could jeopardize or would compromise the patient’s ability to participate in any study assessments., Is severely affected with a UMSARS part IV score of 5., Is suspected of having a neurodegenerative disease other than MSA, in the opinion of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method